week 6 reading

Question 1

what is clinical research

Answer 1

the systematic attempt to improve health and well-being by identifying improved methods to prevent, treat and cure disease and illness

Question 2

in particular what should informed consent provide

Answer 2

• understand the risks, potential benefits, procedures, and alternatives to the study in question

Question 3

what is the first item on the ICH good clinical practices guidelines

Answer 3

states that the potential participants should understand ‘the study involves research’

Question 4

the CIOMS guidelines first item

Answer 4

individuals understand they are being invited to participate in research

Question 5

2 purposes that informed consent serves

Answer 5

1. allows competent individuals to decide whether participation in research is consistent with their interests
2. informed consent allows individuals to decide for themselves whether they will enroll in the study in question

Question 6

participants should understand at least 3 aspects of participation in clinical research

Answer 6

1. research contribution
2. research relationship
3. research impact

Question 7

what is research relationship

Answer 7

the investigators will rely on participants efforts to gather the generalizable knowlede to benefit others

Question 8

participants suffer from ‘therapeutic misconception’, what is this?

Answer 8

assuming that the relationship they have with the investigators is equivalent to the relationship patients have with their clinicians

Question 9

what is wrong with the argument to anonymize samples?

Answer 9

it ignores the fact that individuals have an interest in the project

Question 10

when should review committees consider waiving informed consent

Answer 10

1. participation in study is minimal contribution
2. participants have limited or no interaction with investigators
3. participation has no or negligible impact on participants

Question 11

suggestion

Answer 11

shorten consent forms